How Does Pre-operative Biliary Drainage in Pancreatic Adenocarcinoma Affect Surgical Outcomes in Pancreatic Cancer Surgery

NCT07444840 | Not Yet Recruiting

• 1 other identifier: DEV114
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pre-operative biliary drainage (PBD) is a procedure used to relieve bile duct obstruction, a common issue in patients with pancreatic cancer. The obstruction occurs when a tumor blocks the bile duct, leading to jaundice and other complications. While PBD can help resolve jaundice and improve liver function, its impact on the overall outcomes of pancreatic cancer surgery is still debated. Recent research has focused on whether PBD before surgery improves patient outcomes, such as surgical success, recovery time, and long-term survival. Some studies suggest that draining the bile before surgery might reduce complications like infections, liver dysfunction, and jaundice-related risks. On the other hand, other research indicates that PBD could increase the chances of infection, delays in surgery, or complications from the procedure itself, such as bile leakage or inflammation. This study will look at patients undergoing pancreaticoduodenectomy to remove their head of pancreas pancreatic ductal adenocarcinoma over 8 years, and will compare the tumour characteristics of patients who have had PBD vs those who have not. Data will be gathered from the already available histological characteristics. No treatment would be affected and no tissue would be affected. This research study will focus on oncological characteristics such as tumour progression and lymphatic spread, with overall patient survival as secondary outcome measures.

Conditions

Pancreatic Ductal Adenocarcinoma (mPDAC); Pancreatic Ductal Adenocarcinoma (PDAC)

Keywords

pancreatic ductal adenocarcinoma; biliary drainage; oncology; T stage; perineural invasion; lymphovascular invasion

Outcome Measures

Primary Outcomes (1)

• lymph Node ratio

  From pathology report

  From the day of resection

Study Arms (2)

Preoperative biliary drainage

Patients who undergo pre op biliary drainage before surgery

Procedure: Pre operative biliary drainage

No pre operative biliary drainage

Patients who proceed straight to surgery

Interventions

Pre operative biliary drainage PROCEDURE

ERCP or PTC

Preoperative biliary drainage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing pancreaticoduodenectomy for pancreatic ductal adenocarcinoma with curative intent

You may qualify if:

• Procedure - Pancreaticoduodenectomy
• Histology - Pancreatic ductal adenocarcinoma at East Lancashire Hospitals NHS Trust
• Age \> 18 years

You may not qualify if:

• Patients \< 18 years of age Patients who had pancreaticoduodenectomy for benign disease Patients who had pancreaticoduodenectomy with any histology other than pancreatic ductal adenocarcinoma Patients who underwent any other procedure for head of pancreas pancreatic ductal adenocarcinoma Patients who have opted out from being part of research as per the MESH database

Sponsors & Collaborators

• East Lancashire Hospitals NHS Trust: lead

Related Publications (6)

• Sewnath ME, Karsten TM, Prins MH, Rauws EJ, Obertop H, Gouma DJ. A meta-analysis on the efficacy of preoperative biliary drainage for tumors causing obstructive jaundice. Ann Surg. 2002 Jul;236(1):17-27. doi: 10.1097/00000658-200207000-00005.

  PMID: 12131081 BACKGROUND

• van der Gaag NA, Rauws EA, van Eijck CH, Bruno MJ, van der Harst E, Kubben FJ, Gerritsen JJ, Greve JW, Gerhards MF, de Hingh IH, Klinkenbijl JH, Nio CY, de Castro SM, Busch OR, van Gulik TM, Bossuyt PM, Gouma DJ. Preoperative biliary drainage for cancer of the head of the pancreas. N Engl J Med. 2010 Jan 14;362(2):129-37. doi: 10.1056/NEJMoa0903230.

  PMID: 20071702 BACKGROUND

• Nadeem SO, Jajja MR, Maxwell DW, Pouch SM, Sarmiento JM. Neoadjuvant chemotherapy for pancreatic cancer and changes in the biliary microbiome. Am J Surg. 2021 Jul;222(1):3-7. doi: 10.1016/j.amjsurg.2020.09.042. Epub 2020 Oct 5.

  PMID: 33039150 BACKGROUND

• Fang Y, Gurusamy KS, Wang Q, Davidson BR, Lin H, Xie X, Wang C. Pre-operative biliary drainage for obstructive jaundice. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD005444. doi: 10.1002/14651858.CD005444.pub3.

  PMID: 22972086 BACKGROUND

• Blacker S, Lahiri RP, Phillips M, Pinn G, Pencavel TD, Kumar R, Riga AT, Worthington TR, Karanjia ND, Frampton AE. Which patients benefit from preoperative biliary drainage in resectable pancreatic cancer? Expert Rev Gastroenterol Hepatol. 2021 Aug;15(8):855-863. doi: 10.1080/17474124.2021.1915127. Epub 2021 May 26.

  PMID: 34036856 BACKGROUND

• Hartwig W, Werner J, Jager D, Debus J, Buchler MW. Improvement of surgical results for pancreatic cancer. Lancet Oncol. 2013 Oct;14(11):e476-e485. doi: 10.1016/S1470-2045(13)70172-4.

  PMID: 24079875 BACKGROUND

Related Links

• Pancreatic Cancer UK

MeSH Terms

Conditions

Neoplasms

Study Officials

• Daren Subar

  East Lancashire Hospitals NHS Trust

  STUDY DIRECTOR

Central Study Contacts

Zak Shehata, MBChB

CONTACT

+447792068440; zakshehata@doctors.org.uk

Daren Subar

CONTACT

Daren.Subar@elht.nhs.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share